Extracellular matrix (ECM) has been long recognized as an important structural component of connective tissues. ECM is generally described as a filamentous structure of glycoproteins and proteoglycans that is attached to the cell surface and provides cells with anchorage, traction for movement, and positional recognition. There is now considerable evidence that the ECM elaborated by cells creates microenvironments that these and other cells will respond to, by differentiating or maintaining their differentiated state. ECM provides a substrate for organization of cells which adhere to it. Tissue based ECM biomaterial and devices have been widely used for a variety of medical applications, such as heart valves, porcine small intestinal submucusa (SIS), human dermis and bovine pericardium. Allogenic or xenogenic connective tissues, such as skin, tendon, pericardium and SIS are decellularized (or devitalized) using known, conventional methods to provide a type of extracellular matrix called acellular matrix, which may also be referred to as decellularized matrix. During decellularization, the cells that lead to tissue rejection are removed while retaining the critical biochemical and structural components of the original tissue.
The use of acellular matrix for certain applications in medical devices is known in the art. One example is bioprosthetic devices for soft tissue attachment, reinforcement, or construction. The devices have a sheet of naturally occurring extracellular matrix and a sheet of synthetic mesh coupled to the naturally occurring extracellular matrix portion. The implants may be dried under vacuum pressure resulting in a physical cross-linking between the laminates of SIS and between the mesh and adjacent SIS laminates.
It is also known to use an acellular matrix with a reinforced biological tissue. The methods to marry or combine the biologic component and non-biological components include tissue around non-biologic component, non-biologic around tissue, or tissue embedded within or coating a knit, weave, braid or other textile of non-biologic component. The two components can be co-mingled or the separated components can be layered and rolled tightly around another. Compressive force may be added to the layered construct by including securing straps, similar to a belt and hoop design.
Known shortcomings and deficiencies of the conventional approaches to combine synthetic constructs with acellular matrix include delamination, poor handling properties, and cumbersome processing techniques. Therefore, there is a need for novel methods for combining an acellular matrix with a synthetic scaffold.